Adaptive Designs for Clinical Trials in Nephrology

CKD affects over 850 million people worldwide. The condition incorporates multiple individual etiologies, complex disease trajectories, and several rare complications, such as calciphylaxis. Barriers to conducting successful clinical trials in kidney diseases may variously include low-incidence conditions, slow disease progression, paucity of surrogate end points, poor tolerance of placebo, lack of evidence for existing practices, and uncertainty about potential treatment effect sizes. Adaptive trial methodologies and the use of perpetual trial platform infrastructure could address some of these and increase the likelihood of clinically meaningful outcomes in kidney disease research.